Sr. Clinical Data Manager

South San Francisco, CA 94080

Posted: 03/13/2019 Industry: Other Area(s) Job Number: 34103

Sr. Clinical Data Manager

The Clinical Data Manager (CDM) is responsible for all aspects of the data management process from the development of project documentation, system set-up, UAT through database lock for assigned studies. The core duties and responsibilities of the CDM are delineated below. 

• Supports budget and resource planning across assigned projects

• Contributes to technical infrastructure of data management

• Participates in CRO/vendor selection process for outsourced activities

• May participate in department or cross-functional initiatives DM/Study

 • Represents data management in study team meetings

• Manages data management timelines to coordinate and synchronize deliverables with the overall study timelines

• Generates and/or reviews/approves study documents (e.g. Data Management Plans, Case Report Forms, data transfer specifications, SAE and/or external data reconciliation plans, coding conventions, study protocols)

• Executes and/or distributes data management metrics, listings, and reports, as required

• Oversight of data management CRO/service providers on assigned studies

• Monitors the progress of all data management activities on assigned studies to ensure project timelines are met

• Provides training on the CRF completion guidelines and EDC system at Investigator meetings and to internal or external team members, as needed

• Proactively identifies potential study issues/risks and recommends/implements solutions

• Responsible for the accuracy and completeness of the clinical data collected during a clinical trial, able to work independently towards the assigned goal

• Provide DM support to Statisticians and Statistical Programmers in production of clinical trial reports and other deliverables Requirements

REQUIRED

• Requires solid knowledge of clinical data management principles, clinical trials process and regulatory requirements

• Excellent verbal/written and interpersonal skills required for working successfully in a cross- functional team environment

• Able to communicate and collaborate effectively with cross-functional teams in face-to-face conversation, by telephone, and by email

• Good working knowledge of ICH, FDA, and GCP regulations and guidelines

• Strong well-rounded technical skills (EDC systems, MS Word, Excel, PowerPoint)

• Knowledge of industry standards (CDISC, SDTM, CDASH)

• Experience with web-based Electronic Data Capture (EDC), clinical data management systems and industry wide thesauri, such as MedDRA and WHO Drug.

• Proven ability to work both independently or in a team setting Education/ Training

• Bachelor degree in Life Sciences, Computer Sciences, Mathematics, or health-related field

• Minimum of 5 years of SENIOR-LEVEL DM (i.e., Sr. CDA) experience in the pharmaceutical or biotechnology industry or equivalent; depth and exposure to DM related tasks considered in lieu of minimum requirement

• CRO management experience desired

• Competence in SAS programming a plus

• Prior oncology/hematology experience highly desirable
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